FDA 510(k) Application Details - K984013

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K984013
Device Name	Unit, Operative Dental
Applicant	PLANMECA OY ASENTAJANKATU 6 HELSINKI 00880 FI Other 510(k) Applications for this Company
Contact	LARS MORING Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/11/1998
Decision Date	01/26/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review